ID

34616

Description

A Study of RO4917838 (Bitopertin) in Patients With Persistent, Predominant Negative Symptoms of Schizophrenia (WN25308); ODM derived from: https://clinicaltrials.gov/show/NCT01192880

Link

https://clinicaltrials.gov/show/NCT01192880

Keywords

Versions (1)
  1. 1/19/19 1/19/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 19, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT01192880

English

Eligibility Schizophrenia NCT01192880

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, aged 18 years and above
Description

Adult | Age

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
diagnosis of schizophrenia of paranoid, disorganized, residual, undifferentiated or catatonic subtype
Description

Paranoid Schizophrenia | Schizophrenia, Disorganized | Residual schizophrenia | Undifferentiated schizophrenia | Schizophrenia, Catatonic

Data type

boolean

Alias
UMLS CUI [1]
C0036349
UMLS CUI [2]
C0036347
UMLS CUI [3]
C0036351
UMLS CUI [4]
C0392322
UMLS CUI [5]
C0036344
predominant negative symptoms
Description

Symptoms Negative Primary

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C1513916
UMLS CUI [1,3]
C0205225
with the exception of clozapine, patients are on any of the available marketed atypical or typical antipsychotics (treatment with a maximum of two antipsychotics)
Description

Exception Clozapine | Atypical antipsychotic Quantity | Typical Antipsychotic Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0009079
UMLS CUI [2,1]
C1276996
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C2917392
UMLS CUI [3,2]
C1265611
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence that patient has clinically significant, uncontrolled and unstable disorder (e.g. cardiovascular, renal, hepatic disorder)
Description

Disease Uncontrolled | Disease Unstable | Cardiovascular Disease | Kidney Disease | Liver disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0443343
UMLS CUI [3]
C0007222
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0023895
body mass index (bmi) of <17 or >40 kg>/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
depressive symptoms, defined as a score of 9 or greater on the calgary depression rating scale for schizophrenia (cdss)
Description

Depressive Symptoms Depression scale Schizophrenia

Data type

boolean

Alias
UMLS CUI [1,1]
C0086132
UMLS CUI [1,2]
C0679604
UMLS CUI [1,3]
C0036341
a severity score of 3 or greater on the parkinsonism item of the esrs-a (clinical global impression, parkinsonism)
Description

ESRS-A - CGI-S Parkinsonism

Data type

boolean

Alias
UMLS CUI [1]
C3899303
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Similar models

Eligibility Schizophrenia NCT01192880

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients, aged 18 years and above
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Paranoid Schizophrenia | Schizophrenia, Disorganized | Residual schizophrenia | Undifferentiated schizophrenia | Schizophrenia, Catatonic
Item
diagnosis of schizophrenia of paranoid, disorganized, residual, undifferentiated or catatonic subtype
boolean
C0036349 (UMLS CUI [1])
C0036347 (UMLS CUI [2])
C0036351 (UMLS CUI [3])
C0392322 (UMLS CUI [4])
C0036344 (UMLS CUI [5])
Symptoms Negative Primary
Item
predominant negative symptoms
boolean
C1457887 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
Exception Clozapine | Atypical antipsychotic Quantity | Typical Antipsychotic Quantity
Item
with the exception of clozapine, patients are on any of the available marketed atypical or typical antipsychotics (treatment with a maximum of two antipsychotics)
boolean
C1705847 (UMLS CUI [1,1])
C0009079 (UMLS CUI [1,2])
C1276996 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C2917392 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Disease Uncontrolled | Disease Unstable | Cardiovascular Disease | Kidney Disease | Liver disease
Item
evidence that patient has clinically significant, uncontrolled and unstable disorder (e.g. cardiovascular, renal, hepatic disorder)
boolean
C0012634 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0007222 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0023895 (UMLS CUI [5])
Body mass index
Item
body mass index (bmi) of <17 or >40 kg>/m2
boolean
C1305855 (UMLS CUI [1])
Depressive Symptoms Depression scale Schizophrenia
Item
depressive symptoms, defined as a score of 9 or greater on the calgary depression rating scale for schizophrenia (cdss)
boolean
C0086132 (UMLS CUI [1,1])
C0679604 (UMLS CUI [1,2])
C0036341 (UMLS CUI [1,3])
ESRS-A - CGI-S Parkinsonism
Item
a severity score of 3 or greater on the parkinsonism item of the esrs-a (clinical global impression, parkinsonism)
boolean
C3899303 (UMLS CUI [1])
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